- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …and batch records in accordance with FDA current Good Manufacturing practices ( cGMP ). In addition, personnel in this position will support the production operation ... than perfection + Thinks creatively with the bounds of cGMP framework to overcome challenges and brings viable solutions...good manual dexterity. + Must possess basic knowledge of cGMP -s. + Must be able to transcribe detailed data… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …by anything less than perfection. + Thinks creatively within the bounds of CGMP framework to overcome challenges and brings viable solutions to the table. + ... specific SME developing, revising and approving all manner of CGMP framework including protocols, SOP-s, BMR-s, risk assessments and...good manual dexterity. - Must possess basic knowledge of CGMP -s. - Must be able to transcribe detailed data… more
- Fujifilm (Research Triangle Park, NC)
- …right place for you. From our Bioprocess Innovation Center to our cGMP -compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether ... maintains inspection readiness, data integrity, and Current Good Manufacturing Practice ( CGMP ) compliance + Partners with management for technical services, such as… more
- West Pharmaceutical Services (Kinston, NC)
- …to ensure that product/customer specifications are followed always. Ideal candidates have previous cGMP experience and have the knowledge of how to operate within a ... rooms such as pre-staging, staging, loading, unloading and final packaging, per cGMP standards. + Strict adherence to product/customer specifications. + Ensure that… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …the highest quality standards. + Maintain documentation and functional work areas to CGMP standards. + Capable of lifting and moving heavy equipment parts and ... good manual dexterity. + Must possess basic knowledge of CGMP -s. + Must be able to transcribe detailed data...be able to transcribe detailed data accurately according to CGMP and SOP standards. + Must be able to… more
- Fujifilm (Holly Springs, NC)
- …Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects ... (pH, conductivity, visual inspection) * Executes validation protocols according to cGMP Standard Operating Procedures (SOPs) * Maintains training to perform all… more
- Cambrex High Point (High Point, NC)
- …and stability monitoring of bulk drug substances and drug products under cGMP guidelines + Independently develop and evaluate methodologies, design and implement ... of project tasks and deliverables + Responsible for ensuring compliance with cGMP and other regulatory guidelines. + Analyze information for technical correctness… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …(-DIO-) is responsible for ensuring the accuracy and reliability of cGMP data and data supporting regulatory submissions. Generally, this requires implementing, ... and implementation of software used for the generation of cGMP data + Conduct audits and gap assessments based...and implementation of software used for the generation of cGMP data + Assess training program and materials for… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …out of our RTP, NC Office.** Ensures current Good Manufacturing Practices ( cGMP ) and FDA/Grifols Quality Systems are adhered to throughout the evaluation, review ... and quality assurance/control documentation. + Assists in the development of cGMP operating procedures that relate to process, computer systems, and equipment… more
- Fujifilm (Holly Springs, NC)
- …of the Drug product filling line + Execute validation protocols according to cGMP Standard Operating Procedures (SOPs) + Own the establishment of processes and ... Degree + 4 years of direct experience in a cGMP manufacturing environment **OR** + BA/BS + 2 years...BA/BS + 2 years of direct experience in a cGMP manufacturing environment + Equivalent Military training or experience… more